New phase 3 clinical trial data has reinforced the therapeutic potential of dupilumab for patients with chronic spontaneous urticaria (CSU) who have not responded adequately to H1-antihistamines, with consistent efficacy demonstrated across all body mass index (BMI) categories.
The findings emerge from the phase 3 LIBERTY-CSU CUPID Study A and Study C trials, presented at the 2025 American Academy of Allergy, Asthma, and Immunology/World Allergy Organization Joint Congress in San Diego. The research showcases dupilumab's ability to significantly reduce both itch severity and urticaria activity in treatment-resistant CSU patients.
Clinical Efficacy Across Patient Populations
A notable aspect of the trials' findings is the consistent therapeutic response observed regardless of patients' BMI, including those in the upper limits of normal and obese ranges. This characteristic particularly distinguishes dupilumab's clinical profile, as treatment efficacy often varies with body weight for many therapeutic agents.
Dr. Thomas Casale, professor of internal medicine at Morsani College of Medicine, University of South Florida, who presented the data, emphasized the significance of these findings. "This will give individuals some reassurance that this drug will work with chronic urticaria," he stated, highlighting the broader implications for patient care.
Therapeutic Implications for Comorbid Conditions
The research also revealed important insights for patients with multiple T2-high diseases. Dr. Casale noted that patients with asthma have a higher likelihood of developing urticaria compared to the general population. The potential for dupilumab to address multiple comorbid conditions simultaneously represents a significant advantage in the therapeutic landscape.
Regulatory Status and Future Prospects
Dupilumab (marketed as Dupixent) is currently under FDA review for CSU treatment, with a target action date of April 18, 2025. The comprehensive efficacy data across different patient subgroups, combined with its established safety profile, positions dupilumab as a promising therapeutic option for CSU patients who have exhausted conventional treatment approaches.
The drug's potential approval would provide a valuable addition to the therapeutic arsenal for CSU management, particularly for patients who have not achieved adequate control with standard antihistamine therapy.
